BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SULZER MEDICA

    MDR report key: 343105 · Received July 20, 2001

    Report

    Report Number
    343105
    Event Type
    Malfunction
    Date Received
    July 20, 2001
    Date of Event
    July 21, 2000
    Report Date
    July 19, 2001
    Manufacturer
    *
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SULZER MEDICA VOLUNTARILY RECALLED SPECIFIC LOTS OF INTER-OP ACETABULAR SHELLS FOLLOWING REVIEW OF MANUFACTURING PROCESS. THIS PT RECEIVED ONE OF THE RECALLED CUPS. PT UNDERWENT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32826 SULZER MEDICA NATURAL-HIP SYSTEM KWY * * 1329010
    32827 SULZER MEDICA TOTAL HEAD, NEUTRAL NECK KWY * * 1431555
    32828 SULZER MEDICA INTER-OP ACETABULAR SYSTEM KWB * * 1427557
    32829 SULZER MEDICA INTER-OP ACETABULAR SYSTEM KWB * * 1379220

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other